idacio

Generic: adalimumab-aacf

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name idacio
Generic Name adalimumab-aacf
Labeler fresenius kabi usa, llc
Dosage Form KIT
Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-558
Product ID 65219-558_08dbaffe-9d05-43cf-b24b-b44ade8685fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761255
Listing Expiration 2026-12-31
Marketing Start 2024-12-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219558
Hyphenated Format 65219-558

Supplemental Identifiers

RxCUI
797544 2699315 2699319

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name idacio (source: ndc)
Generic Name adalimumab-aacf (source: ndc)
Application Number BLA761255 (source: ndc)

Resolved Composition

Strengths
  • 40 mg/0.8 ml
  • 1 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (65219-558-08) * .8 mL in 1 VIAL, GLASS (65219-562-01) * 1 SWAB in 1 POUCH (65219-332-95)
source: ndc

Packages (1)

65219-558-08 1 KIT in 1 CARTON (65219-558-08) * .8 mL in 1 VIAL, GLASS (65219-562-01) * 1 SWAB in 1 POUCH (65219-332-95)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

IDACIO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "08dbaffe-9d05-43cf-b24b-b44ade8685fc", "openfda": {"rxcui": ["797544", "2699315", "2699319"], "spl_set_id": ["08dbaffe-9d05-43cf-b24b-b44ade8685fc"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (65219-558-08)  *  .8 mL in 1 VIAL, GLASS (65219-562-01)  *  1 SWAB in 1 POUCH (65219-332-95)", "package_ndc": "65219-558-08", "marketing_start_date": "20241209"}], "brand_name": "IDACIO", "product_id": "65219-558_08dbaffe-9d05-43cf-b24b-b44ade8685fc", "dosage_form": "KIT", "product_ndc": "65219-558", "generic_name": "adalimumab-aacf", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IDACIO", "application_number": "BLA761255", "marketing_category": "BLA", "marketing_start_date": "20241209", "listing_expiration_date": "20261231"}